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Fri., October 15, 2010

Acid reflux meds on rise in babies, but are they effective?

Six-Month-Old Grace Scholl looks at her mom Anna Scholl Monday October 11, 2010 in their Cedar Rapids home. Anna and her husband Josh put Grace on the acid reflux medication Pravacid "We did the Pravacid because I couldn't stand to see our baby in pain," Anna said. (Becky Malewitz/ SourceMedia Group News)

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Spit up and sleep deprivation come with newborns, but a growing number of parents are seeking acid reflux medications to ease their babies’ blues.

The U.S. Food and Drug Administration has not approved some of the most common acid reflux drugs — Prevacid, Nexium and Prilosec — for children younger than a year, because studies show the drugs are not effective for infants. Yet, use of acid blockers in infants has skyrocketed in recent years.

“We were given the choice of waiting it out or putting her on Prevacid,” Anna Scholl, 27, of Cedar Rapids, said of her baby, Grace. “We did the Prevacid, because I couldn’t stand to see our baby in pain.”

Acid blockers, advertised with catchy nicknames like the “Purple Pill,” have proved useful for adult heartburn or acid reflux. Proton pump inhibitors (PPIs), a class of acid blockers that includes Nexium, Prevacid and Prilosec, were the third-most-mentioned drug — behind aspirin and cholesterol-lowering Lipitor — during doctor visits in 2006, according to a Centers for Disease Control and Prevention National Health Statistics report from 2008.

Many parents hope these drugs will relieve their babies’ spitting up, crying and perceived abdominal pain. The problem, say gastroenterologists, is that these drugs don’t stop spitting up, crying or perceived abdominal pain, and they may bring a slight risk of bacterial infection because of lack of acid in a baby’s stomach.

“Babies do cry, and babies do spit up. That doesn’t mean they go together,” said Warren Bishop, a professor of pediatrics and director of gastroenterology at the University of Iowa Children’s Hospital.

Spitting up is normal for babies, who consume a liquid diet that is relatively large compared to their bodies, Bishop said. Babies also have a short distance from tummy to mouth and spend a lot of time lying flat — factors that cause frequent regurgitation.

Anna and Josh Scholl were concerned when Grace, then 3 months old, started having bouts of crying after she nursed. Grace never napped for more than 15 minutes during the day and arched her back, which Scholl saw as a sign of abdominal pain.

Scholl cut dairy and caffeine from her diet to see if Grace was having an allergic reaction through breast milk but saw no immediate improvement.

The Scholls’ pediatrician diagnosed Grace with reflux and wrote a prescription for Prevacid.

“I did some research at home and talked with other mothers. I didn’t see any negative research,” Scholl said.

It took two weeks, but Grace’s symptoms got better, her mother said. The few occasions when they did not give Grace the medicine, the baby’s crying and erratic sleep returned. The family did not notice any side effects.

“We took her off at 5 months (of age), because it resolved itself,” Scholl said. “She still spits up all the time, but she’s not having the symptoms on the same scale.”

Some parents believe acid blockers help their children, others don’t, said Wes Machnowski, a pediatric gastroenterologist in Cedar Rapids.

“There is also a placebo effect. Parents may feel better that they are treating their child with medicine,” he said.

Stevie Hardesty Toomey, 26, of Iowa City, has what physicians would call a “happy spitter.” Four-month-old Eleanor spits up after meals, but she doesn’t have other signs of reflux. Even if Eleanor was extremely fussy, Hardesty Toomey said she would be reluctant to try medicine.

Many parents dealing with a screaming infant who doesn’t sleep and refuses to eat are willing to try anything, said Beth Anderson, an Ames native who now lives in Washington. Anderson founded the Pediatric Adolescent Gastroesophageal Reflux Association in 1992 after dealing with her daughter’s frequent regurgitation.

“She was waking up seven times a night, screaming bloody murder, and we couldn’t get her on the weight chart,” Anderson said.

Anderson and her husband scoured medical journals to find out what was wrong her their daughter, who they called “the Velcro baby” because she cried if put down. Anderson’s website, Reflux.org, now gets about 1 million hits a month and features lively parent discussion boards.

Acid blockers are often seen as the salvation for a colicky baby—that is, a healthy baby who has long periods of crying for no apparent reason — but medical research shows acid blockers don’t ease crying.

Infants treated with PPIs did not show a significant decrease in pain and discomfort perceived to be caused by reflux, according to a March article in the Annals of Pharmacotherapy. In a study of 160 infants in the United States and Poland in 2006 and 2007, Prevacid had the same effect at reducing crying jags as a placebo, according to the April 2009 issue of the Journal of Pediatrics.

Although the FDA hasn’t approved PPIs for infant use, the surge in prescriptions is documented in a 2007 study in the Journal of Pediatric Gastroenterology and Nutrition. The study of four U.S. health care plans showed PPI use in infants quadrupled from 2000 to 2003.

Acid blockers have few side effects for infants but could make babies more vulnerable to swallowed bacteria usually killed by stomach acid, doctors said. Acid blockers for infants also can cost up to $120 a month.

Increased use of acid blockers among infants has failed to spur more research on the population.

“Until such studies show efficacy, every prescription we write for acid suppressive treatment for these symptoms in infants is a prescription for an experiment,” wrote gastroenterologists Susan Orenstein of the University of Pittsburgh and Eric Hassall of the University of British Columbia in an editorial to the 2007 study.

Anna Scholl also wishes there was more information about acid blockers for infants. Grace, now 6 months, is an active child who weighs a healthy 16.5 pounds. Her blue eyes fix on her mother as she opens her mouth for a bite of homemade baby food.“The lack of research makes it more difficult for parents to know what is best,” Scholl said.

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